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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Leachables Study


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General
Study Status Progress Adequate
Application Number P080012 / PAS003
Date Current Protocol Accepted 05/04/2012
Study Name Leachables Study
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source Other Data Source
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a non-clinical study.
Study Population Description Not applicable. This is a bench/lab study.
Sample Size 8 Prometra pumps will be used in this study.
Data Collection Leachables Testing

The leachables study will use eight (8) Prometra pumps as required in the condition of approval. The solutions will be placebo solutions at the appropriate corresponding pHs. At each time-point pumps will be emptied of their contents through the catheters and 15 mLs of solution will be used for leachable testing. Pumps will then be refilled with 22 mL of placebo solutions. This schedule mimics actual use of the pumps (dispensing and refilling) and will allow sufficient sample for the leachables testing.



Controlled Extraction Study

The control extraction studies will involve the evaluation of extraction solutions of the materials of the Prometra pumps that come into contact with the drug product formulation. The accelerated extractions will be done using an Accelerated Solvent Extraction. The solvents to be used for extraction are purified water, water adjusted to pH 9.5, isopropanol, and hexane. The materials of the pump will be extracted in each of these solvents at reflux for 24 hours.
Follow-up Visits and Length of Follow-up Not applicable. This is a bench/lab study.


Leachables Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/07/2012 07/24/2012 On Time
one year report 02/06/2013 02/06/2013 On Time
18 month report 08/07/2013 08/05/2013 On Time
two year report 02/06/2014 02/06/2014 On Time
three year report 02/06/2015 02/06/2015 On Time
four year report 02/06/2016 02/05/2016 On Time
five year report 02/05/2017 02/13/2017 Overdue/Received
six year report 02/05/2018 02/13/2018 Overdue/Received
seven year report 02/05/2019    
eight year report 02/05/2020    
nine year report 02/04/2021    
ten year report 02/04/2022    


Contact Us
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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